MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	PFO OCCLUDER
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 35mm amplatzer pfo occluder was chosen for implant using a 10f amplatzer trevisio intravascular delivery system.The device was prepared per the ifu.After the device was positioned, the device was deployed but the right disc would not flatten out.It was reported that the right disc was bulbous in shape and resembled a hamburger.There was no noticed problem with the left disc.The deformed device was not released from the delivery cable while inside the patient.The device was recaptured and removed from the patient.A second 35mm amplatzer pfo occluder was then chosen for implant using the same 10f delivery system.After the replacement device was released from the delivery cable, a small space had formed between the right disc and the septum resulting in a small amount of blood flow in between the right disc and the septum.However, it was confirmed via transesophageal echocardiogram (tee) that the pfo was completely closed, and the device was stable.There was no clinically significant delay and the patient remained hemodynamically stable throughout the procedure.The patient was reported as discharged.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Information from field indicated that a10f delivery sheath was used, there was no interaction with cardiac structures during deployment, or no angulation or kink in the delivery system was noted.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER PFO OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16287203
• Report Number: 2135147-2023-00378
• Device Sequence Number: 11982116
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 8423399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male